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Ann Thorac Surg 1997;63:522-528
© 1997 The Society of Thoracic Surgeons

Original Article: Cardiovascular

Clinical Application of Transluminal Endovascular Graft Placement for Aortic Aneurysms

Kanji Inoue, MD, Tomoyuki Iwase, MD, Mitsuru Sato, Me, Yuki Yoshida, Mt, Terumitsu Tanaka, MD, Yasunobu Kubota, MD, Shunichi Tamaki, MD, Koji Hasegawa, MD, Ario Yamazato, MD

Departments of Cardiovascular Surgery, Cardiology, and Clinical Laboratory, Takeda Hospital, and Third Division, Department of Internal Medicine, Kyoto University Hospital, Kyoto Japan

Accepted for publication September 27, 1996.


   Abstract
Top
 Footnotes
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background. In recent years, transluminal endovascular graft placement techniques have been developed for the treatment of aortic aneurysms. We report our initial clinical experience with endovascular graft placement using a graft developed in our laboratory.

Methods. The procedure was performed in 20 patients with a diagnosed aortic aneurysm. The graft is constructed from a Dacron cylinder, and the surface of the graft is supported with multiple rings of extraflexible wire. After the compactly folded graft is delivered through the sheath to the predetermined target point, the graft is deployed and then pressed against the vessel by balloon inflation. Straight graft insertion was attempted in 10 patients, bifurcated graft insertion in 8, and branched graft insertion in 2.

Results. Graft placement was successful in 19 of the patients and unsuccessful in 1. There were no cases of graft migration, aneurysm rupture, or graft destruction during a mean follow-up period of 9 months.

Conclusions. Initial clinical results demonstrated the efficacy and safety of endovascular graft placement using this graft.


   Introduction
Top
 Footnotes
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
See also page 528.

Patients at high risk for aortic aneurysm rupture have generally been treated surgically. However, in recent years, the feasibility of placing prosthetic grafts transluminally for the treatment of aortic aneurysms has been demonstrated in experimental and clinical studies [1–10]. In 1989, Inoue began to design and develop a graft that would permit aortic aneurysms to be managed nonsurgically. After long-term, extensive animal studies in which the graft was tested [1, 2], a clinical trial was initiated in which 20 patients with a diagnosed aortic aneurysm received the graft. We describe our initial clinical experience in repairing aortic aneurysms using this device.


   Material and Methods
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 Acknowledgments
 References
 
Patients
Between October 1994 and February 1996, 20 patients with an aortic aneurysm underwent transluminal endovascular graft placement at Takeda Hospital. The patients' characteristics are summarized in Table 1Go. There were 15 male and 5 female patients, aged 49 to 85 years (mean age, 72 years). There was a true aneurysm in 13 patients, aortic dissection in 5, a true aneurysm and aortic dissection in 1, and a pseudoaneurysm in 1. Three patients had previously undergone surgical graft replacement. All patients gave their informed consent in conformance with the protocols approved by the institutional review board of Takeda Hospital.


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  		Table 1. . Patient Characteristics
 
Patient Selection
For a patient to qualify to receive the graft, his or her proximal and distal neck had to be at least 10 mm long. Iliac artery stenosis, which can be successfully managed by percutaneous transluminal angioplasty, was not a contraindication. Although the procedure is applicable to patients with an iliac artery aneurysm, for such a patient to receive the graft at least one internal iliac artery had to be completely patent. Large internal mesenteric arteries in patients with abdominal aortic aneurysms were considered to be contraindications to the procedure. Insofar as possible, we tried to maintain the patency of any intercostal arteries in patients with thoracic artery aneurysms.

Endovascular Grafting System
The endovascular grafting system comprises a graft, a detachable carrying wire, a detachable traction wire, a balloon catheter, and an introducer sheath (Fig 1Go). The graft is constructed from a Dacron cylinder, and the surface of the graft is supported by multiple rings of extraflexible wire. A loosely spun Dacron filament covers the rings so that the graft can be anchored securely to the aortic wall without injurying it. To further facilitate graft fixation, each middle ring is attached with a pair of 3- to 5-mm-long wire barbs, which hook into the aortic wall. That the barbs do not perforate the aorta was confirmed by the previously performed animal experiments [1, 2]. Radiopaque marks, which can be observed fluoroscopically, are attached to the ring at each end of the graft. Bifurcated and branched grafts can also be constructed by simple modifications in this basic design. The diameter and length of each graft are given in Table 2Go. Owing to their flexibility, grafts in any configuration can be evenly and compactly folded so that they readily fit into a 16F to 22F sheath.



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  		Fig 1. . The way in which the graft is constructed and fixed to the carrying wire. (The relative sizes of the components of the system as shown are not as they actually are.)

 

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  		Table 2. . Graft Size in 19 Patients
 
The graft was fixed to the carrying wire and traction wires as follows. The carrying wire was constructed from a hollow stainless steel tube, and a spring coil was attached to its tip to prevent injury to the aortic wall. As shown in Figure 1Go, the carrying wire had a side hole and two short loops of thread were attached under the side hole. The two loops were then passed through a pair of small ears attached to the proximal end of the graft at diametric positions and then fixed at the side hole using a 0.20-mm nickel titanium wire, which was inserted throughout the length of the carrying wire. The traction wire was constructed in a fashion similar to that of the carrying wire and was attached to the distal end of the graft using essentially the same method as that just described. Release of the graft from the carrying and traction wires was easily achieved by retracting the 0.20-mm nickel titanium wire.

Bifurcated and branched grafts were attached to the carrying and traction wires in a similar manner and the traction wires connected to the respective distal limbs. However, two types of traction wires were used for these types of grafts-those made of a hollow stainless steel tube and those made of polyethylene (flexible traction wire). The assembled graft was evenly folded with the aid of a funnel, then it was encased in a cartridge until use. The sheath was 16F to 22F in diameter. A hemostatic valve was attached at the outer end of the sheath.

Transluminal Endovascular Graft Placement Procedure
STRAIGHT GRAFTS.
After the intravenous administration of heparin, the sheath was inserted through the puncture or arteriotomy site in the femoral artery and advanced beyond the target point. The cartridge holding the graft was connected to the sheath, then the graft was introduced into the sheath and advanced to the predetermined target point under fluoroscopic guidance. Once the graft was in the optimal position, only the sheath was withdrawn, while the carrying wire was held in place (Fig 2Go, 1), thereby allowing the graft to rapidly expand by its own flexibility (Fig 2Go, 2). Once the graft was placed at the optimal point, the balloon catheter was advanced into the graft. The balloon was inflated using an intraortic balloon pumping system, and the graft was pressed back into its original shape (Fig 2Go, 3). After the graft placement was completed, the graft was released from the carrying and traction wires by removing both nickel titanium wires in their lumens. Finally, the carrying wire and traction wire were removed (Fig 2Go, 4).



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  		Fig 2. . Transluminal endovascular graft placement procedure. (1) Graft is advanced to the predetermined target point. (2) Graft is released from the sheath. (3) Graft is pressed against the aortic wall by balloon inflation. (4) Carrying and traction wires are removed.

 
BIFURCATED GRAFTS.
Unlike straight grafts, the tips of the bifurcated graft limbs were folded using loops of thread and nickel titanium wires (0.25 mm) in such a way that the graft would not spontaneously expand after its release from the sheath until the titanium wire was removed. The flexible traction wire was attached to the left (right) limb. To place the graft, the sheath was introduced into the abdominal aorta through the right (left) femoral arteriotomy. After the folded graft was advanced through the sheath to the target point, only the sheath was pulled back while the carrying wire was held firmly. A 10F guiding catheter was then inserted into the bifurcation over the flexible traction wire. The free end of the flexible traction wire was folded back, inserted again into the guiding catheter, and advanced to the bifurcation (Fig 3Go). The free end of the flexible traction wire attached to the left (right) limb was then caught and withdrawn to its full extent using a gooseneck snare wire, which was inserted percutaneously through the left (right) femoral artery. At the same time, the traction wire attached to the other limb was pulled back fully. After the graft was in position, the folded tip of each graft limb was deployed by removing the nickel titanium wires. The graft was then pressed against the aortic wall by balloon inflation and the carrying system removed.



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  		Fig 3. . The free end of the flexible traction wire attached to the left (right) limb is caught by a gooseneck snare wire.

 
BRANCHED GRAFTS.
The branched graft, which had a sidearm that extends into one of the great vessels of the aortic arch, was placed into the distal arch, including the left subclavian artery. The traction wire was attached to each distal end of the main and sidearm grafts and the grafts individually folded. The sheath was introduced into the descending thoracic aorta through a femoral arteriotomy, and the folded branched graft was introduced into the sheath and advanced to the descending thoracic aorta. With the sheath held firmly, only the graft was advanced to the aortic arch using the carrying wire. The free end of the flexible traction wire attached to the sidearm was then caught and pulled back using a gooseneck snare wire, which was inserted percutaneously through the left brachial artery. After the branch graft was positioned in place by manipulating the carrying wire and both traction wires, the folded graft was deployed. The graft was released from the carrying system and pressed against the aortic wall by balloon inflation.

PATIENT FOLLOW-UP.
All patients have been followed up in our department. Spiral computed tomography, color-flow duplex Doppler echocardiography, or transesophageal echocardiography, or a combination of these, was performed within 1 week to evaluate the position of the graft and the patency of the lumen and to look for complications. If it was found necessary, aortography was also performed. These examinations were then repeated at 1, 3, and 6 months after the procedure and after that at 6-month intervals.


   Results
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 Acknowledgments
 References
 
All patients underwent the procedure under local anesthesia. The grafts were inserted percutaneously in 2 patients using the delivery system and in 18 patients through open arteriotomies. The configurations of the grafts and implantation sites used are summarized in Table 3Go. The procedure was successfully completed in all patients, with the sole exception of patient 5. None of the 20 patients died of procedure-related causes during or after the procedure (Table 4Go). Typical aortograms obtained before and after the procedure are shown in Figures 4 to 6GoGoGo. The procedure was terminated in patient 5, who had a true aneurysm in the distal arch, because the branched graft did not pass through the 22F sheath used. This failure was due to two coincidental technical difficulties: First, the graft with a branch proved to have a relatively large profile in the folded state, and second, the sheath was considerably bent along the arched aorta near the targeted site. These difficulties were effectively circumvented in the subsequent patient (patient 13) who received a branched graft by releasing the graft from the sheath shortly before the aorta began to arch and also by advancing it to the targeted position using the carrying wire while it was still folded.


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  		Table 3. . Graft Configuration and Implantation Site
 

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  		Table 4. . Complications of Endovascular Grafting
 


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  		Fig 4. . Aortograms of abdominal aorta before and after the procedure in patient 7. Arrows show each end of the graft. (Left) Before the procedure, an aortogram showed an infrarenal abdominal aortic aneurysm. (Right) After the procedure, an aortogram showed good flow of contrast medium through the bifurcated graft, with no leakage.

 


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  		Fig 5. . Aortograms of aortic arch to descending thoracic aorta before and after the procedure in patient 16. Arrows show each end of the graft. (Left) Before the procedure, an aortogram showed a large focal aortic ulcer with a type B aortic dissection. (Right) The graft was positioned in the distal arch to exclude flow into the aneurysmal sac. Aortogram demonstrated complete resolution of the aortic ulcer after the procedure.

 


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  		Fig 6. . Aortograms of abdominal aortic aorta before and after the procedure in patient 10. Arrows show each end of the graft. (Left) Before the procedure, an aortogram showed an infrarenal abdominal aortic aneurysm and large common iliac aneurysms with a severe tortuosity. (Right) Right limb was placed into the right common iliac artery and left limb was placed into the left external iliac artery. After the procedure, a small proximal leakage occurred.

 
Microembolization occurred in 2 patients, one of whom had transient cerebral ischemia (patient 5) and one of whom had tibial artery occlusion (patient 15). Patient 15 also had paralysis of the right leg because of occlusion of the right internal iliac artery. Thrombosis of the aneurysm surrounding the graft was complete in 12 patients within 1 week. The remaining 7 patients had either proximal or distal communication with the aneurysm. The degree of leakage was small in 6 patients (patients 2, 4, 10, 13, 16, and 18) and large in 1 (patient 6). Although aortography revealed complete resolution of the aneurysm after the procedure in patients 13 and 16, transesophageal echocardiography detected trivial proximal communication with the aneurysm. Transcatheter embolization was subsequently performed in patient 6 to obliterate the residual communication with his pseudoaneurysm. Although the leakage was less after the procedure, a small leak persisted and the aneurysm was only partially thrombosed because of his abnormal coagulation state. All patients with leakage have continued to be observed closely, and a second endovascular grafting procedure has been planned. No patients have shown a serious complication such as graft migration, aneurysm rupture, resultant aneurysm formation, aneurysm enlargement, graft destruction, significant graft stenosis, or a change in the configuration of the graft, during a mean follow-up period of 9 months (range, 4–19 months).


   Comment
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
Acknowledgments
 References
 
Various types of grafts and stents have been developed since 1969, when Dotter inserted stainless steel coils as a vascular stent in canine popliteal arteries [10–12]. The endovascular grafting system described in this report was designed and developed by us. Grafts made of Dacron proved to be strong and durable, provided good sealing, and could be folded compactly. As already noted, the outside surface of the graft was supported by multiple rings of extraflexible wire. The inside was smooth to prevent thrombogenesis. The middle rings were attached to the graft to prevent its collapse. The wire rings were sufficiently flexible and elastic to prevent injury to the aortic wall. The graft was found to be very flexible; it could be bent to conform to curved portions of the vessel, such as the aortic arch and the neck of an infrarenal abdominal aortic aneurysm that was very tortuous.

Our endovascular grafting system was easy to use, thanks to its extreme flexibility and low profile. This allowed it to be inserted regardless of whether there was a severe vascular tortuosity or luminal irregularities. An additional important feature of the delivery system was the precision with which the graft could be placed. The graft could be moved easily to an optimal position using the carrying wire or traction wire, even after the graft was released from the confines of the sheath.

Another advantage of our system was our use of an intraaortic balloon pumping system. The balloon was inflated during diastole because a considerable afterload would be exerted on the heart and graft migration might occur if the balloon were inflated during systole. The small grafts such as the sidearm of a branched graft were inflated manually.

Our endovascular grafting system made it possible to place both bifurcated graft and branched grafts. For example, we used it successfully to perform an endovascular repair of a type B aortic dissection with an intimal tear just beyond the left subclavian artery (patient 13). If the long-term results prove to be favorable, this should open the way for use of the procedure in a larger proportion of patients with aortic aneurysms.

Spinal cord injury resulting from obstruction of the internal iliac artery on one side was a rare risk associated with the standard surgical repair of abdominal aortic aneurysm. However, one of our patients suffered paralysis of the right leg resulting from occlusion of the right internal iliac artery; this patient had an infrarenal abdominal aortic aneurysm. In this patient the left limb of the bifurcated graft was placed into the common iliac artery and the right limb was placed into the external iliac artery because the distal common iliac artery was aneurysmal. It is unclear whether both internal iliac arteries needed to be perfused. However, whenever possible, we try to maintain the patency of both internal iliac arteries.

Perigraft leakage occurred in 7 patients. The main cause of leakage in these patients was an incorrect graft size resulting from the fact that these patients had marked aortic tortousity which made it difficult to obtain the precise measurements necessary for the construction of a customized prosthesis. Figure 6Go shows the aortogram obtained in patient 10 who had an abdominal aortic aneurysm, large iliac artery aneurysm, and severe aortic tortuosity. Although the aneurysm was almost completely thrombosed after the procedure, a small proximal communication persisted. To prevent leakage, the entire circumference of the second and third rings as well as of the first one at either end was stitched to the Dacron cylinder in the grafts used in later patients, so that both ends of the graft made tighter contact with the aortic wall. This modification proved to be effective in eliminating the perigraft leakage.

Although it is uncertain whether the trivial leakage may lead to delayed aneurysm rupture, the possibility cannot be excluded. Therefore, we currently consider that a delayed second procedure should be performed to obliterate such persistent leakage.

Our preliminary experience demonstrates the efficacy and the safety of transluminal endovascular graft placement using the graft and delivery system we have developed. We believe that the procedure may become an alternative to the surgical treatment for aortic aneurysms. However, careful long-term evaluation and further improvement in the devices and techniques will be necessary before it can be used extensively in clinical practice.


   Acknowledgments
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
References
 
We express our deep appreciation to Dr Katsuya Shigesada, Institute for Virus Research, Faculty of Medicine, Kyoto University, for reading the manuscript and giving valuable comments and to Dr Tadao Serikawa, Institute of Laboratory Animals, Faculty of Medicine, Kyoto University, for permitting the use of facilities for animal experiments.


   Footnotes
Top
 Footnotes
Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Address reprint requests to Dr Inoue, Department of Cardiovascular Surgery, Takeda Hospital, Higashiiru, Nishinotoin, Shiokojidori, Shimogyo-ku, Kyoto 600, Japan.


   References
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Inoue K, Htay T, Kida M, Fujiwara H. Percutaneous implantation of aortic endovascular graft for created aneurysm: animal experiment [abstract]. Circulation 1991;84(Suppl 2):421.
  2. Inoue K, Htay T. Long-term follow-up of percutaneously placed aortic endovascular graft: animal experiment [abstract]. Circulation 1992;86(suppl 1):636.
  3. Yoshioka T, Wright KC, Wallace S, Lawrence DD Jr, Gianturco C. Self-expanding endovascular graft: an experimental study in dogs. AJR 1988;151:673–6.[Abstract/Free Full Text]
  4. Mirich D, Wright KC, Wallace S, et al. Percutaneously placed endovascular grafts for aortic aneurysms: feasibility study. Radiology 1989;170;1033–7.[Abstract/Free Full Text]
  5. Chuter TAM, Green RM, Ouriel K, Fiore WM, DeWeese JA. Transfemoral endovascular aortic graft placement. J Vasc Surg 1993;18:185–97.[Medline]
  6. Moon MR, Dake MD, Pelc LR, et al. Intravascular stenting of acute experimental type B dissections. J Surg Res 1993;54:381–8.[Medline]
  7. Kato N, Hirano T, Takeda K, Nakagawa T, Mizumoto T, Yuasa H. Treatment of acute aortic dissections with expandable metallic stents: experimental study. J Vasc Interv Radial 1994;5:417–23.
  8. Marin ML, Veith FJ, Penetta TF, et al. Percutaneous transfemoral insertion of a stented graft to repair a traumatic femoral arteriovenous fistula. J Vasc Surg 1993;18:299–302.[Medline]
  9. Moore WS, Vescera CL. Repair of abdominal aortic aneurysm by transfemoral endovascular graft placement. Ann Surg 1994;220:331–41.[Medline]
  10. Dake MD, Miller DC, Semba CP, Mitchell S, Walker PJ, Liddell RP. Transluminal placement of endovascular stent-grafts for the treatment of descending thoracic aortic aneurysms. N Engl J Med 1994;331;1729–34.[Medline]
  11. Dotter CT. Transluminally-placed coilspring endoarterial tube grafts: long-term patency in canine popliteal artery. Invest Radiol 1969;4;329–32.[Medline]
  12. Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg 1991;5:491–9.[Medline]

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